Effects of Post-Stroke Upper Extremity Assistance

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05036642
Collaborator
(none)
16
1
1
12
1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to quantify the improvement of post- stroke individuals' ability to move their arms during and after robot assisted therapy.

While researchers know that robot assisted therapies improve motor performance over the course of weeks, they do not know how motor performance is affected over the course of minutes or hours. A better understanding of how robot assisted therapies affect motor performance on short time scales may help us to prescribe more effective therapy doses to maximize motor recovery after neurological injury.

The study will allow us to obtain a detailed understanding of the performance of the device as described above.

Condition or Disease Intervention/Treatment Phase
  • Device: Compliant Passive Arm Support
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Post-Stroke Upper Extremity Assistance
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stroke Survivors

Stroke survivors with upper extremity motor impairments

Device: Compliant Passive Arm Support
The device is a mechanical device that consists of two linkages, elastic bands, a commercial posture brace, and a hook-and-loop fastener. The design of the device, with several compliant elements, ensures that one device fits many without joint alignment concerns. No motors or other actuators add energy into the system, meaning that it is stable.

Outcome Measures

Primary Outcome Measures

  1. Action Research Arm Test (ARAT) Action Research Arm Test (ARAT) [Change in ARAT score from baseline (without the device) assessed after approximately 60 minutes of use with the device.]

    The ARAT is a 19 item measure divided into 4 subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). ARAT measures activities of daily living, coordination, dexterity, upper extremity function.

Secondary Outcome Measures

  1. Reachable Workspace [Change in from baseline (without the device) of Range of Motion assessed after approximately 60 minutes of use with the device.]

    Participants will be instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. A larger workspace area indicates fewer upper extremity motor impairments.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • greater than 6 months post-stroke

  • passive abduction to 90 degrees at shoulder

  • reduced active (retro)flexion/extension at shoulder when abducted at 90 degrees

  • reduced active flexion/extension at elbow

Exclusion Criteria:
  • unable to give informed consent

  • unable to comprehend and follow instructions

  • have a condition (other than stroke) affecting sensorimotor function

  • show evidence of unilateral spatial neglect

  • unable to sit in a chair without armrests for 2 hours

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University CHARM Lab Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Allison Okamura, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Allison Okamura, Professor of Mechanical Engineering, Stanford University
ClinicalTrials.gov Identifier:
NCT05036642
Other Study ID Numbers:
  • IRB-61540
  • SNI-BI1-02
First Posted:
Sep 5, 2021
Last Update Posted:
Sep 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021